Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

Official Title ICMJE

Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

Brief Summary

Research study which involves the use of a combination of an Enriched Hematopoetic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow your body to develop "tolerance" to the transplanted kidney. Tolerance means that your body would see the transplanted kidney as part of you and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Recruiting

Estimated Enrollment ICMJE

60

Estimated Completion Date

March 2031

Estimated Primary Completion Date

March 2026 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure

Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation

Patient is receiving a renal transplant only

The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the pheresis.

Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion

Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF

No evidence of donor-specific antibody presently or historically

Panel Reactive Antibody (PRA) less than or equal to 20

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four hour drive, for the first month of the protocol so that we can monitor them closely in the early post transplant period. As long as there is insurance or funding that will cover the cost of the transplant and any research related complications, it is not necessary for the subjects to be US citizens to participate in this trial.

Exclusion Criteria:

Clinically active bacterial, fungal, viral or parasitic infection

Pregnancy

Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant or FCRx infusion

Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)